Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

PreScription: Comments on the FDA Guidance "Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry"

Author(s):  Allen Loyd V Jr

Issue:  Mar/Apr 2022 - Volume 26, Number 2
View All Articles in Issue

Page(s):  92

PreScription: Comments on the FDA Guidance

Download in electronic PDF format for $75

Abstract:  

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, U.S. Food and Drug Administration, FDA, Code of Federal Regulations, FDA Guidance for Industry, Federal Food, Drug, and Cosmetic Act section 503A, drug product, pharmaceutical equivalence, pharmaceutical alternatives, finished dosage form

Related Categories: LEGAL, DOSAGE FORMS/DRUG CARRIERS

Printer-Friendly Version



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
Final Guidance for Pharmacy Compounding of Human Drug Products Under Section 503A
Blankenship Cynthia E
Sep/Oct 2014
Pg. 379-380

PreScription: Comments on the FDA Guidance "Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry"
Allen Loyd V Jr
Mar/Apr 2022
Pg. 92

Determining Whether a Substance is Legal to Compound with Under Section 503A of the FDCA
Cabaleiro Joe
Sep/Oct 2021
Pg. 358-362

Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines
Allen Loyd V Jr
Jul/Aug 2016
Pg. 351

View Sample
Allowing Compounding Pharmacies to Address Drug Shortages
Broughel James
Mar/Apr 2022
Pg. 100-109

U.S. Food and Drug Administration Proposed Guidance Document: Compounding Animal Drugs from Bulk Substances
Miller David G
Jul/Aug 2015
Pg. 303-305

PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs
Allen Loyd V Jr
Sep/Oct 2017
Pg. 356

Rapid-Dissolve Technology: An Interview With Loyd V. Allen, Jr., PhD, RPh
Allen Loyd V Jr
Nov/Dec 2003
Pg. 449-450

U.S. Food and Drug Administration "Evaluation Criteria" for Difficult to Compound Drugs
Allen Loyd V Jr
Nov/Dec 2015
Pg. 487-488

PreScription: Drug Quality and Security Act Implementation Subcommittee Hearing
Allen Loyd V Jr
Mar/Apr 2018
Pg. 92

Nonsterile Basics of Compounding: Using U.S. Food and Drug Administration-approved Commercial Products as Ingredients
Allen Loyd V Jr
Nov/Dec 2023
Pg. 474-481

U.S. Food and Drug Administration List of Drugs NOT to be Used in Compounded Medications for Humans (The Negative List)
Nov/Dec 2016
Pg. 457-458

Standing Together Fixing the Drug Quality and Security Act
Miller David G
Mar/Apr 2015
Pg. 104-106

Compounding OTC Drugs: A Legal Perspective
Gibbs Jeffrey N
, Mazan Kate Duffy
May/Jun 2000
Pg. 180-181

Drugs Banned for Use in Food Animals: An Explanation
Davidson Gigi S
Mar/Apr 2001
Pg. 101-103

PostScription: Drug Disposal: Compounding Pharmacists' Involvement in the Prevention of Prescription Drug Misuse and Abuse
Williams LaVonn A
Nov/Dec 2011
Pg. 526-527

Drug Shortages & Discontinued Drugs: The Effects on Patients and Healthcare Providers
Allen Loyd V Jr
, Williams LaVonn A
Jul/Aug 2012
Pg. 294-298

U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies
Yoch Doug
Mar/Apr 2017
Pg. 95-102

International Academy of Compounding Pharmacists' Legislative Regulatory Update: Take Action! Stop the U.S. Good and Drug Administration's Misguided Veterminary Guidance
Miller David G
Nov/Dec 2015
Pg. 449-450

Nominations of Difficult to Compound Drugs to the U.S. Food and Drug Administration--Pharmacy Compounding Advisory Committee: Part 1
Allen Loyd V Jr
Sep/Oct 2015
Pg. 389-390

Return to Top